Lee Kwang-Bok, Johnson Jared S, Song Kyung-Jin, Taghavi Cyrus E, Wang Jeffrey C
Department of Orthopaedic Surgery, University of California, Los Angeles, CA, USA.
J Spinal Disord Tech. 2013 Jul;26(5):233-8. doi: 10.1097/BSD.0b013e3182440162.
A retrospective study.
To evaluate whether recombinant human bone morphogenetic protein (rhBMP-2) can improve fusion rates and time to fusion in high-risk patients when compared with autograft in lumbar posterolateral fusion.
The use of rhBMP-2 in the general population for posterolateral fusion has resulted in relatively good reported outcomes; however, it is currently considered "off-label" use. Few studies, however, have determined the outcomes of rhBMP-2 when used in patients with numerous risk factors for a pseudarthrosis.
One hundred ninety-five patients were divided into 4 groups depending on fusion material and the presence/absence of fusion-related risk factors for nonunions; group A was defined as rhBMP-2 used in the presence of high-risk factors (FRRF), group B was defined as rhBMP-2 used in the absence of FRRF, group C was defined as autograft used in the presence of FRRF, and group D was defined as autograft used in the absence of FRRF. The time to fusion, fusion rate were compared between each group.
The time to fusion was significantly faster in group B than in group D in patients with no history of smoking (P<0.05), hypertension (P<0.01), or other significant comorbidity (P<0.05). The time to complete fusion was also significantly faster in group B than in group D in patients under the age of 65 (P<0.05), patients undergoing primary surgery (P<0.05), single-level surgery (P<0.01), no smoking history (P<0.05), no diabetes mellitus (P<0.01), no hypertension (P=0.001), no osteoporosis (P<0.01), and no significant comorbidity (P<0.01). Although the fusion rate was higher in group B than in group D, with the exception of sex and single-level surgery, there were no significant differences between groups B and D. Although initial fusion mass and time to solid fusion was faster in group A than in group C, there were no significant differences between groups A and C. In addition, fusion rates were higher in group C than in group A, looking at all factors except revision surgery, but the differences were not statistically significant.
With relative low dosage of rhBMP-2 compared with the dose used in Food and Drug Administration trial, in patients without fusion-related risk factors, rhBMP-2 may lead to acceptable fusion rates and faster fusion time when compared with autograft. Therefore, rhBMP-2 may serve as an acceptable alternative to autogenous bone graft in patients without fusion-related risk factors undergoing instrumented posterolateral lumbar fusions. When compared with patients with fusion-related risk factors, the use of rhBMP-2 was comparable with autograft but was not sufficient to overcome all aspects of the weakened osteoinductive capacity encountered in patients with these risk factors.
一项回顾性研究。
评估与自体骨移植相比，重组人骨形态发生蛋白（rhBMP-2）在腰椎后外侧融合的高危患者中是否能提高融合率及缩短融合时间。
在普通人群中使用rhBMP-2进行后外侧融合已取得相对良好的报道结果；然而，目前其属于“未按药品说明书用药”。然而，很少有研究确定rhBMP-2用于有大量假关节形成风险因素患者的结果。
195例患者根据融合材料及是否存在与融合相关的不愈合风险因素分为4组；A组定义为在存在高危因素（FRRF）时使用rhBMP-2，B组定义为在不存在FRRF时使用rhBMP-2，C组定义为在存在FRRF时使用自体骨移植，D组定义为在不存在FRRF时使用自体骨移植。比较每组之间的融合时间和融合率。
在无吸烟史（P<0.05）、高血压（P<0.01）或其他显著合并症（P<0.05）的患者中，B组的融合时间明显快于D组。在65岁以下（P<0.05）、初次手术（P<0.05）、单节段手术（P<0.01）、无吸烟史（P<0.05）、无糖尿病（P<0.01）、无高血压（P=0.001）、无骨质疏松（P<0.01）及无显著合并症（P<0.01）的患者中，B组完成融合的时间也明显快于D组。尽管B组的融合率高于D组，但除性别和单节段手术外，B组和D组之间无显著差异。虽然A组的初始融合块和达到坚实融合的时间比C组快，但A组和C组之间无显著差异。此外，从除翻修手术外的所有因素来看，C组的融合率高于A组，但差异无统计学意义。
与美国食品药品监督管理局试验中使用的剂量相比，rhBMP-2剂量相对较低，在无融合相关风险因素的患者中，与自体骨移植相比，rhBMP-2可能导致可接受的融合率和更快的融合时间。因此，在接受器械辅助腰椎后外侧融合且无融合相关风险因素的患者中，rhBMP-2可作为自体骨移植的可接受替代物。与有融合相关风险因素的患者相比，rhBMP-2的使用与自体骨移植相当，但不足以克服这些风险因素患者中遇到的骨诱导能力减弱的所有方面。
